Coeliac disease (CD) is a chronic disorder causing inflammation of the small intestine from gluten ingestion. Most cases of the disease remain undiagnosed, and population screening is inaccessible due to a complex and expensive diagnosis pathway. ITAMA proposes a rapid, efficient and cost-effective method for CD screening that combines a novel IT solution based on an AI self-learning algorithm with standard point of care testing (POCT).
Problem worth solving
Coeliac disease is a condition where the body’s immune system attacks its own tissues upon consumption of gluten. This damages the gut’s lining and affects the ability of the body to properly absorb nutrients from food. CD affects over 70 million people worldwide and incidence is increasing significantly over time in several regions of the world. A high number (80%) of CD cases remain undiagnosed, partly because the gold standard diagnosis path (duodenal biopsy) is invasive, time consuming and cost intensive. This has a huge impact on the economies of nations through missed work days and burden for health care systems. The only known treatment is a strict gluten free diet, but as most cases remain undiagnosed, the vast majority of affected individuals are unaware that they need to follow this diet.
Typically, the population at large can effectively be screened for several different conditions by POCT. CD has had issues in this respect, as although there is a need for screening, POCT alone have not been enough to give exact results. Instead, a more complicated, expensive and invasive two-phase testing methodology has been required for a reliable positive or negative diagnosis of CD.
ITAMA aims to enhance the efficiency of POCT diagnostics for coeliac disease, while rendering the procedure much less invasive and less costly than the current method. A POCT is combined with a software tool, which uses a specific questionnaire to map the situation of each test subject and then an algorithm to predict the probability of a positive CD diagnosis. This will give a reliable method to screen large populations and could also provide a faster, more cost effective and easier path to the final diagnosis. Consequently, previously undiagnosed cases can be effectively revealed, enhancing the diagnosis rate and minimising morbidity for a large number of patients as well as the huge unnecessary costs to society. The results were confirmed in a trial of 20.000 school children, and a combination of POCT and symptom questionnaire for making the celiac disease diagnosis, matched the sensitivity of taking an endoscopic biopsy.
The market for ITAMA is expected to overlap significantly with the market for the corresponding POCT. The POCT market is strong and growing rapidly. The global market is expected to reach USD 46.7 billion by 2024 from USD 28.5 billion in 2019, at a CAGR of 10.4%.
According to the business model chosen, market segments may include POCT kit manufacturers, state or regional medical authorities, medical software companies or consumers, via private health practitioners.
The ITAMA software solution together with the associated POCT is a diagnosis methodology that is expected to compete with the validated laboratory and clinical tests currently in use to diagnose CD. These include serologic tests, genetic testing, video capsule endoscopy (VCE) and endoscopy with duodenal biopsy.
ITAMA is a low cost, low investment solution for a big problem affecting many people and society at large. It is both much quicker and much less expensive than the current diagnosis pathway for CD. The solution is technically simple and with the right partner, the market penetration can be less challenging than that for medical applications on average.
ITAMA is developed by a multidisciplinary team of academic researchers across two countries in the disciplines of medicine and ICT, with existing collaborations with government and industry.